Intra-aortic Balloon Counterpulsation in Patients Undergoing Cardiac Surgery

Not Applicable

• Conditions: Postoperative; Dysfunction Following Cardiac Surgery
• Interventions: Device: Intra-aortic balloon pump.

• Registration Number: NCT02143544
• Lead Sponsor: University of Sao Paulo

Brief Summary

The hypothesis of the study is to evaluate if the preoperative placement of IABP reduces clinical complications in high-risk patients undergoing cardiac surgery.

Detailed Description

High-risk patients undergoing cardiac surgery are at high risk for myocardial ischemia, arrhythmia, cardiogenic shock and other clinical complications. Different therapeutic options are available to support these patients in the perioperative period including inotropes, vasopressors, and vasodilators, and also assist devices such as intra-aortic balloon pump (IABP) and others.

IABP increases myocardial oxygen supply by increasing diastolic coronary perfusion pressure and decreases myocardial oxygen demand by reducing left ventricular afterload. Additionally, IABP can also improve cardiac output and systemic perfusion. The hypothesis of this randomized and controlled trial is that the placement of IABP immediately before the cardiac surgery reduces clinical complications in high-risk patients.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-30
• Study First Submitted QC: 2014-05-18
• Study First Posted: 2014-05-21
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-03
• Last Update Posted: 2016-02-04
• Primary Completion: 2016-04
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Age equal to or higher than 18 years old
• EuroSCORE equal to or higher than 6 or ejection fraction equal to or lower than 40%
• Written informed consent

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Exclusion Criteria

• Cardiogenic shock
• Acute myocardial infarction (AMI) < 48 hours
• Mechanical complications of AMI
• Peripheral vascular disease (aorta, iliac or femoral)
• Severe aortic regurgitation
• Neoplasm
• Pregnancy
• Tachyarrhythmia
• Procedures of the aorta
• Coagulopathy
• Thrombocytopenia
• Cardiac transplantation, congenital heart disease or endocarditis
• Refusal to consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoperative intra-aortic balloon pump.	Intra-aortic balloon pump.	Intervention: Preoperative placement of the intra-aortic balloon pump.

Primary Outcome Measures

Name	Time	Method
Composite 30-day mortality or major morbidity (mechanical ventilation > 24 hours, mediastinitis, surgical reexploration, stroke, cardiogenic shock, acute renal failure)	30 days	Composite outcome of 30-day mortality or incidence of patients presenting a major complication according to modified Society of Thoracic Surgeons (STS): mechanical ventilation \> 24 hours, deep sternal wound infection/mediastinitis, surgical reexploration, stroke, cardiogenic shock and acute renal failure.

Secondary Outcome Measures

Name	Time	Method
Evaluation of hemodynamic data	48 hours	Comparison of the following hemodynamic data between groups: heart rate, arterial pressure and cardiac output.
Delirium	30 days	Acute cognitive dysfunction diagnosed with the use of the CAM-ICU scale within 30 days after randomization
Bleeding	24 hours	Blood losses exceeding 100-300 mL per hour following ICU admission
Duration of mechanical ventilation	30 days	Number of days during mechanical ventilation.
IABP complications	30 days	Number of patients presenting one of the following: lower limb ischemia, mesenteric ischemia or bleeding.
Use of vasoactive agents	30 days	Number of days and dose of inotropes and vasopressors.
Levels of biomarkers	7 days	Comparison of the following biomarker levels between groups: pro-BNP (Brain natriuretic peptide), troponin I and Neutrophil gelatinase-associated lipocalin (NGAL), Heart-type Fatty Acid Binding Protein (H-FABP)
Echocardiographic parameters	7 days	Comparison of the following echocardiographic parameters between groups: left ventricular ejection fraction, cardiac output, left ventricular diastolic diameter, left ventricular systolic diameter and wall motion abnormalities.
Costs	30 days	Comparison of overall costs between groups.
30-day mortality	30 days	Death during hospital stay or death after hospital discharge until 30 days following the procedure
60-days mortality	60 days	Death until 60 days following the procedure
1-year mortality	1 year	Death until 1 year following the procedure
Acute Kidney Injury	30 days	Incidence of acute kidney injury according the Acute Kidney Injury Network (AKIN) classification.
Cardiovascular complications	30 days	Arrhythmias or myocardial ischemia within 30 days after randomization
Infectious complications	30 days	New infection or septic shock within 30 days after randomization

Trial Locations

Locations (1)

Heart Institute; 🇧🇷 Sao Paulo, SP, Brazil